Implantation system for annuloplasty rings

ABSTRACT

Methods for reconfiguring an atrioventricular heart valve that may use systems comprising a partial or complete annuloplasty rings proportioned to reconfigure a heart valve that has become in some way incompetent, a pair of trigonal sutures or implantable anchors, and a plurality of staples which may have pairs of legs that are sized and shaped for association with the ring at spaced locations along its length. These systems permit relative axial movement between the staples and the ring, whereby a patient&#39;s heart valve can be reconfigured in a manner that does not deter subtle shifting of the native valve components. Shape-memory alloy material staples may have legs with free ends that interlock following implantation. Annuloplasty rings may be complete or partial and may be fenestrated. One alternative method routes a flexible wire, preferably of shape-memory material, through the bights of pre-implanted staples. Other alternative systems use linkers of shape-memory material having hooked ends to interengage with staples or other implanted supports which, following implantation, decrease in effective length and pull the staples or other supports toward one another so as to create desired curvature of the reconfigured valve. These linkers may be separate from the supports or may be integral with them and may have a variety of shapes and forms. Various of these systems may be implanted non-invasively using a delivery catheter.

[0001] This application is a continuation-in-part of PCT/IB02/05570,filed Dec. 19, 2002, which claims priority from U.S. ProvisionalApplication Serial No. 60/342,824 filed Dec. 21, 2001. The disclosuresof both applications are incorporated herein by reference.

FIELD OF THE INVENTION

[0002] This invention relates to prosthetic annuloplasty ring systemsdesigned to surgically correct defects in heart valves and moreparticularly to method and systems for the efficient and effectiveimplantation of corrective rings and the like.

BACKGROUND OF THE INVENTION

[0003] Rheumatic, connective tissue or ischemic heart diseases mayheavily affect the configuration of the atrioventricular heart valves.Diseased valves may become narrow, incompetent or both. A great manypatients suffering from ischemic heart disease, who previously underwentmyocardial infarctions, consequently develop various degrees of mitralvalve incompetence. Typically in those patients, the valve may grosslyseem to be normal; yet its annulus is dilated, causing coaptation orinterengagement of the leaflets to be disturbed and resulting inincompetence of the valve. Such patients will benefit from anannuloplasty as a repair, either alone or in addition to arevascularization procedure, i.e. coronary artery bypass surgery. Mostbut not all mitral and tricuspid valves are amenable to reconstruction,and the etiology of valvular disease has an important bearing on theindication for repair. A rheumatic valve is probably the most difficultto conserve; conversely, degenerative valves with thin and redundanttissue, elongated or ruptured chordae, and/or a dilated annulus are verylikely to be repairable. Ischemic regurgitation can often be repairedwith annuloplasty.

[0004] Annuloplasty rings have now become essential components ofreconstructive surgery of the mitral and tricuspid valves. Their safetyand durability have been proven in numerous clinical studies that haveoccurred since their genesis in the late 1960's when Dr. AlainCarpentier introduced the prosthetic ring. This completely rigid ringhad the systolic shape of the mitral and tricuspid valve; once suturedin place, the ring permanently stabilized the valve annulus into thisshape. He designed a series of multi-sized fabric-covered rings with astainless steel or a titanium core, which were configured to approximatethe original shape of the diseased or dysfunctional valve annulus.Multiple sutures were sewn around the periphery of the annulus creatingan entire circle of guide lines. The ring was positioned on the valveannulus, and the guide lines were then attached to the ring and used todraw the valve opening to the configuration of the ring (which would bethe approximate shape of the original valve annulus). Although Dr.Carpenter's method could significantly improve valve function, somesurgeons believe that the rigid structure of rings of this type maycompromise the natural flexibility of the valve components. An open orpartial ring annuloplasty prosthesis is described in U.S. Pat. No.4,164,046; it discloses a uniquely shaped open ring useful for mitraland tricuspid annuloplasty having a special velour exterior.

[0005] Subsequent experimental and clinical echocardiographic studiesshowed that the mitral and tricuspid annuli change continuously in sizeand shape during the cardiac cycle. These results induced Dr. CarlosDuran, in 1975, to develop a completely flexible ring that could adaptto such changes. His fully flexible annuloplasty ring could only beshortened in the posterior segment by the placement of placatingsutures; however, judgment of the position, size and spacing of thesesutures requires skill and experience. Other adjustable annuloplastyrings are described in U.S. Pat. Nos. 4,042,979 and 4,290,151. Anothertype of flexible ring design is shown in U.S. Pat. No. 5,450,860 whichincludes an open ring in the form of a wide, flexible ligament that isimplanted into the valve annulus. The ligament is typically made ofexpanded polytetrafluoroethylene to provide flexibility, promote tissueingrowth and allow sutures to readily pass therethrough.

[0006] Although flexible rings may avoid constraining the naturalflexibility of the annulus while still improving valve function, thereare some disadvantages in using flexible rings. For example, when thesuture spacing along the annulus is not matched to the spacing on thering, tension in the tissue may result and cause tissue puckering. Lossof annulus flexibility may also occur over time should scarring andstiffening of the valve annulus develop as a result of the large numberof sutures needed, and such may result in a valve physiology that issimilar to that of a rigid ring, somewhat compromising the naturalflexibility of the valve.

[0007] Studies were also done as to determine whether these flexibleannuloplasty rings would entirely correct the problems witnessed withregard to annuloplasty rings in general. As a result, it is believedthat such a flexible ring may lower the risk of dehiscence because ofreduced tension on sutures that would otherwise occur during systole,and such may also reduce the negative consequences of somewhatinaccurate placement of annuloplasty ring sutures, which could result inmalrotation of the ring. It is also felt that such may minimize the riskof systolic anterior motion (SAM) when a left ventricular outflow tractobstruction occurs, which is a potential and fairly frequentcomplication associated with the use of a completely rigid ring in themitral position. However, they still have not proved to be a completesolution to these problems.

[0008] U.S. Pat. No. 6,524,338, issued Feb. 25, 2003, shows the staplingof a flexible, generally C-shaped band that fits over the prosteriorvalve annulus of a mitral valve while it is being held in place in theannulus by a positioning instrument to which it is releasably sutured.Staples stored in a magazine of a stapling device are individually fedfrom a delivery section at spaced locations along the outer periphery ofthe flexible band so as to attach outer regions of the band to the hearttissue.

[0009] With the improvements in cardiopulmonary bypass and myocardialprotection on one hand and in life expectancy on the other hand, anincrease in interest in valve reconstructions and demand for improvednovel technologies is foreseen. With careful patient selection, valvereconstruction should exhibit significant benefits compared with valvereplacement, to wit: (1) decreased operative mortality and latemortality rates; (2) improved hemodynamics due to better preservation ofleft ventricular function; (3) fewer thromboembolic complications andreduced risk anticoagulant-related hemorrhage, particularly whencompared with the installation of mechanical prostheses; (4) reducedrisk of infected endocarditis; (5) greater durability leading to lowerpercentage of reoperations; and (6) reduced operating costs.

[0010] In summary, the prevailing techniques that are now usedthroughout the world, without resorting to a full valve replacement,generally employ an annuloplasty ring to reduce a great part of thecircumference of the valve. This is accomplished by suturing into placean elastic, semi-rigid or rigid ring that is smaller than the nativeannulus being reduced; the ring may be of a closed shape or an open bandor C-shape. Installation takes place using regular sutures, in much thesame manner as when a full valve replacement is carried out, and theprocedure may consume as much time as a full valve replacement, forexample, an average of about 35 to 45 minutes. Accordingly, improvedannuloplasty systems and methods of reducing this time of surgery havecontinued to be sought.

SUMMARY OF THE INVENTION

[0011] The invention provides implantation systems and methods forimplanting annuloplasty rings or the like which not only can beaccomplished in a reduced time period but which are effective to achievebetter coaptation of the leaflets following implantation. These systemsresult in improved hemodynamic functioning and substantially eliminatethe risk of over-correction. Staples may be employed to affix aprosthesis to the patient's valve annulus in a manner to allow relativemovement axially of the ring.

[0012] Certain such implantation systems may employ especially designedstaples to implant an annuloplasty ring that may be of essentially anydesign, open or closed, generally replacing all the sutures previouslyused but the two trigonal sutures. Such staples can be delivered througha pistol-like applicator of the type generally used for surgicalstapling to close wounds and the like. In one embodiment, such staplesare initially implanted to provide a well-defined and easily installedpathway through which a flexible annuloplasty device can be routed andthen ultimately secured in place by ligation to the two trigonalsutures. In other embodiments, staples or other supports are used toimplant a ring or a partial or open ring of current design or to implanta fenestrated partial ring, that has been prepositioned in desiredorientation on the patient's annulus. Further embodiments utilizespecialized supports that have linkers of shape-memory materialconnected thereto, which linkers form a chain support followingimplantation. Some of these systems may be used to non-invasivelyreconfigure the mitral valve via a delivery catheter routed through theaortic valve into the left ventricle.

[0013] In one particular aspect, the invention provides a method ofreconfiguring an atrioventricular heart valve, which method comprisesproviding an annuloplasty ring sized and shaped to have a desiredconfiguration, and implanting said ring at the mitral or tricuspid valveof a patient by implanting a plurality of staples in the patient's hearttissue so as to spatially position said annuloplasty ring in areconfiguration association therewith, while allowing the tissue inwhich said staples are implanted to have the ability to shift axiallywith respect to said ring.

[0014] In another particular aspect, the invention provides a method ofreconfiguring an atrioventricular heart valve, which method comprisesimplanting supports along a portion of the annulus of the mitral ortricuspid valve of a patient in a pattern extending from about onecommissure toward the opposite commissure to provide a pathwaytherebetween, said supports being implanted in spaced apart locationsand extending above the tissue surface so as to provide a series ofupstanding posts, and interconnecting said upstanding posts usingshape-memory material which decreases in length subsequent toimplantation, said shape-memory material thus causing the valve toassume the desired curvature following implantation.

[0015] In a further particular aspect, the invention provides a systemfor reconfiguring an atrioventricular heart valve, which systemcomprises a partial or complete annuloplasty ring having a size andshape proportioned to reconfigure a heart valve of a patient that hasbecome in some way incompetent, a pair of pledgetted trigonal sutures,and a plurality of staples having pairs of legs that are sized andshaped for association with said ring at spaced locations along thelength thereof in a manner that permits relative axial movement of saidring, whereby a patient's heart valve can be reconfigured in a mannerthat does not deter subtle shifting of the native valve components.

[0016] In a still further aspect, the invention provides a system forreconfiguring an atrioventricular heart valve of a patient that hasbecome in some way incompetent by the creation of a generally annularchain that decreases in length following implantation in a patient,which system comprises a plurality of supports having anchor sectionsthat are shaped for implantation into annulus tissue at spaced locationsalong a path that extends generally from commissure to commissure, and aplurality of linkers having arms made of shape-memory material which areadapted to interconnect adjacent of said supports along said path tocreate such a chain extending generally for a substantial distance alonga path from one commissure to the opposite commissure, whereby apatient's heart valve is reconfigured when said linker arms decrease ineffective length, which reconfiguration does not deter subtle shiftingof the native valve components.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017]FIG. 1 is a top perspective view showing a mitral valve with apair of trigonal sutures extending from the commissures thereof.

[0018]FIG. 2 is a plan view of an annuloplasty ring that might beassociated with the valve of FIG. 1 to reconfigure it.

[0019]FIG. 3 is a perspective view similar to FIG. 1 with theannuloplasty ring similar to that shown in FIG. 2 located in desiredassociation with the native annulus of the patient's valve, with the twotrigonal sutures extending through a fabric covering of the ring.

[0020]FIG. 4 is a view similar to FIG. 3 showing the annuloplasty ringstapled in secure position.

[0021]FIGS. 5, 5A and 6 are front views of three different staples thatmight be employed to complete the implantation of the annuloplasty ringto the tissue of the patient.

[0022]FIG. 5B is a side view of the staple shown in FIG. 5A.

[0023]FIGS. 6A and 6B are perspective views of two additional styles ofstaples which might alternatively be used.

[0024]FIG. 7 is a view similar to FIG. 1 showing a tricuspid valve withtwo trigonal sutures in place.

[0025]FIG. 8 is a view similar to FIG. 3 with a flexible annuloplastypartial ring associated with the valve of FIG. 7.

[0026]FIG. 9 is a view similar to FIG. 8 showing the partialannuloplasty ring stapled into place with the trigonal sutures ligatedthereto.

[0027]FIG. 10 is a view similar to FIG. 1 showing a mitral valve with apartial annuloplasty ring in place and with the ends thereof associatedwith the trigonal sutures.

[0028]FIG. 11 is a plan view of a single wire partial annuloplasty ringschematically illustrating the preferred systematic placement of staplesin association therewith.

[0029]FIG. 12 is a plan view of a fenestrated partial annuloplasty ring.

[0030]FIG. 13 is a view similar to FIG. 10 showing the fenestratedpartial ring of FIG. 12 stapled in position with its ends ligated to thetrigonal sutures.

[0031]FIG. 14 is a view similar to FIG. 1 of a mitral valve showing apattern of staples implanted from commissure to commissure along asection of the native ring of the diseased mitral valve.

[0032]FIG. 14A is a fragmentary perspective view which shows analternative embodiment to that illustrated in FIGS. 14-16, illustratingan alternative method of using the staple supports to a change a valveconfiguration.

[0033]FIG. 14B is a fragmentary perspective view similar to FIG. 14Ashowing the chain after the linkers have effectively shortened in lengthand thus pulled the staple supports closer to one another.

[0034]FIG. 14C is an elevation view of a linker seen in FIG. 14A.

[0035]FIG. 15 is a schematic view showing a needle attached to the leadend of a flexible annuloplasty band disposed in a sheath and ready to berouted from one commissure to the other through the pattern of implantedstaples, with the tail band being shown connected to the ends of theleft-hand trigonal suture.

[0036]FIG. 16 is a perspective view of the valve of FIG. 14 with thepartial annuloplasty band of FIG. 15 located in place and with thesheath removed to show a pair of flexible wires, the ends of which areligated to the respective trigonal sutures.

[0037]FIG. 17 is a perspective view of an anchor that can be used withan alternative system embodying various features of the invention.

[0038]FIGS. 18 and 19 show two partial annuloplasty rings that may beemployed as part of such system along with the anchor posts shown inFIG. 17.

[0039]FIGS. 20 and 21 are schematic perspective views showing theinstallation of a system incorporating a wire annuloplasty ring similarto that illustrated in FIG. 19.

[0040]FIGS. 22 and 23 are perspective views illustrating the systemdepicted in FIG. 20 using an alternative shape-memory staple.

[0041]FIG. 24 is an elevation view, enlarged in size, of an implantablesupport having a linker arm made of shape-memory material.

[0042]FIG. 25 is a similar front elevation view of the support of FIG.24 showing it after it has reached body temperature and reverted to itsoriginal undulating shape.

[0043]FIG. 26 is a view of a mitral valve, similar to that shown in FIG.14, where a plurality of the linker arm supports of FIG. 24 have beenimplanted from commissure to commissure along a section of the native ofthe diseased mitral valve.

[0044]FIG. 27 is a view showing the implanted system of FIG. 26 afterthe individual linker arms have returned to their original shapes,decreasing the effective length of each arm and reconfiguring the shapeof this section of the mitral valve.

[0045]FIG. 28 is perspective view of an alternative embodiment of alinker arm support of the general type shown in FIG. 24.

[0046]FIG. 29 is a perspective of the linker arm support of FIG. 28after it has reverted to its original shape.

[0047]FIG. 30 is a perspective view of another alternative embodiment ofa linker arm support similar to that shown in FIG. 28.

[0048]FIG. 31 is a front elevation view of the support shown in FIG. 30.

[0049]FIG. 32 is a schematic view showing two of the linker supports ofFIGS. 30 and 31 after they have reached body temperature and reverted totheir original shapes so as to schematically show the interengagement atone end between the respective linker arms of the two adjacent supports.

[0050]FIG. 33 is an exploded perspective view showing a furtheralternative embodiment of an implantation system for reconfiguring anatrioventricular heart valve having some similarities to thatillustrated in FIGS. 30-32.

[0051]FIG. 34 is a fragmentary schematic view showing in elevation theimplanted system of FIG. 33 after the anchor portion of the support haschanged its shape.

[0052]FIG. 35 is a view similar to FIG. 34 showing the implanted systemof FIG. 33 after the hook sections of the linkers have changed in shapeto become essentially closed loops.

[0053]FIG. 36 is a perspective view of a portion of a chain of linkersand supports constructed from the elements of FIG. 33, showing thesystem after the arms have shortened in effective length.

[0054]FIG. 37 is a perspective view showing an alternative embodiment ofa anchor portion of a central support similar to that as illustrated inFIG. 33 wherein there are four separate legs that spread radially at 90angles to one another.

[0055]FIG. 38 is a perspective view of another alternative embodiment ofa central support that could be substituted for that shown in FIG. 33wherein the base is of generally wire form.

[0056]FIG. 39 is a perspective view of an alternative embodiment of alinker to that shown in FIG. 36, showing it after it has returned to itsoriginal shape.

[0057]FIG. 40 is a schematic view showing a delivery catheter holding achain of interconnected supports designed for use in non-invasivelyshortening the circumstance of a mitral valve.

[0058]FIG. 41 is a cross sectional view through a section of thedelivery catheter taken generally along the line 41-41 of FIG. 40.

[0059]FIG. 42 is a schematic view showing the delivery catheter insertedinto the left ventricle through the aortic valve as it is beingpositioned to forcefully insert a row of interlinked supports into theheart tissue.

[0060]FIG. 43 is a fragmentary view showing an initial portion of thechain of interlinked supports in place along the annulus of the mitralvalve as the delivery catheter is being moved along the path to insertthem one at a time.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0061] It has been found that, through the use of supports, such asstaples and preferably staples of a preferred design, an improvedannuloplasty system can be created that can be installed, for example,with the use of only two U-shaped, pledgetted trigonal sutures, in lessthan one-half the time it presently takes to install the presentgeneration of annuloplasty rings. For purposes of this application, theterm “annuloplasty ring” is intended to include complete generallyD-shaped rings as well as open rings or bands that may have a generallyC-shape and which are rigid or flexible; in any event, an annuloplastyring system which is used will be proportioned so as to reconfigure anatrioventricular heart valve that has become incompetent or in someother way defective.

[0062] Heretofore, the incorporation of an annuloplasty ring hasinvolved an operation that generally required about as much time insurgery as an actual total valve replacement. However, using the presentinvention, this time can be reduced by 50% or more, thus substantiallyshortening the time when the patient need be on artificial life supportand making surgeons more willing to use an annuloplasty procedurewhenever felt feasible. Installation using certain embodiments of theinvention can be carried out by first positioning an annuloplasty ringin association with the annulus of the valve to be reconfigured and thenapplying staples, or alternatively by first implanting a series ofspaced apart supports, such as staples along the valve annulus to createa desired pathway for an annuloplasty ring of open configuration andthen routing such a ring through portals provided by the supportsdefining such pathway. Methods of implantation where a ring is firstjuxtaposed with the heart tissue are first described, followed by othermanners of implantation.

[0063]FIG. 1 shows a mitral valve having a pair of trigonal pledgettedsutures 11 extending from the commissures thereof. Pledgetted sutureswhich are placed at the respective commissures act both as markers whichposition the annuloplasty ring, and as tie-down sutures that are ligatedat the completion of the implantation operation. Such are the only twosutures that are employed in implanting a closed annuloplasty ring suchas the ring B shown in FIG. 2. The ring 13 has a core 15 that issuitably covered. The core 15 may be solid or may contain a coiledhelical spring or the like as known in this art, if a flexible ring isdesired. The ring 13 is of generally circular cross section; however,rings of different cross sections may be employed as describedhereinafter. The core may be covered with a thin layer 17 of abiocompatible fabric, such as woven polyester, which fabric mayoptionally be associated with expanded polytetrafluoroethylene sheetmaterial. Suture needles 18 at the opposite ends of the trigonal sutures11 are threaded through the fabric 17 as shown in FIG. 3. The suturesare later ligated once the ring has been secured in place by attachmentto the valve annulus via staples. After gauging the valve to select theproper size ring 13, the annuloplasty ring is located in associationwith the native annulus of the patient's valve as shown in FIG. 3, withthe two trigonal sutures 11 extending through the fabric covering 17 ofthe ring.

[0064] Once the annuloplasty ring is positioned in contact with theannulus ring of the mitral valve to be reconfigured, it is quicklysecured in the exact desired position by the implantation of staples 19,(see FIG. 4); the staples in this embodiment are individually secured tothe valve tissue at spaced apart locations about the entire length ofthe ring so as to spatially secure it radially while allowing the tissueto move axially of the ring. Surgical staples having a pair of legs maybe implanted using any suitable commercially available surgical staplerof which there are quite a variety being marketed today. Examples ofsuch staplers include those shown in U.S. Pat. Nos. 5,782,397 and5,918,791.

[0065] Once about 7-10 spaced-apart staples 19, which may be of any,suitable design, have been applied about the ring 13 along its entirelength to secure the ring radially about the valve, as shown in FIG. 4,the two trigonal pledgetted sutures 11 are ligated to the annuloplastyring. Ligation completes the implantation, and the entire operation willtake less than one-half the time it takes to presently install a similarannuloplasty ring using a myriad of sutures as is currently commonpractice.

[0066] Although a variety of staples may be employed as generally knownin the surgical stapling art, ceratin preferred staples are illustratedhereinafter. FIG. 5 illustrates a staple 21 having a pair of legs 23that are formed with two inwardly protruding, opposed bends 25 which arelocated at the tissue surface. In their operative orientation, the legscreate a portal 27 that will be located above the surface of the tissueto which the annuloplasty ring is being secured. The staple 21 willpreferably reasonably closely surround the ring 13, which may be ofcircular cross-section, so as to effectively restrain it againstmovement in a radial direction while allowing free relative movement ofthe staple (and thus the valve tissue) along the length of the ring.Free ends 28 of the two legs 23 of the staples are customarily pointed,and they may be originally or subsequently curved at the time ofimplantation so as to secure the staples in the tissue. Preferably, thestaples 21 are made of a shape-memory material, such as taught in U.S.Pat. No. 4,485,816, the disclosure of which is incorporated herein byreference; for example, they may be made of Nitinol, a metal alloymaterial. For example, the staples may be originally formed in theirdesired closed shape and subsequently cooled below a transitiontemperature before deforming them into an open shape. It is conceivablethat other types of shape-memory material might be used which wouldregain an initial configuration following implantation after treatmentwith energy, e.g., UV radiation or the like. After placement in thevalve tissue, the staples 21 will revert to their original closed shape,and they will be capable of generating sufficient stress to penetratethrough the tissue in which they reside so that the free ends 28 assumea secure orientation. More preferably, the free ends 28 of the staplesare formed so as to interlock with each other, as by providinginterlocking barbs 28 a, and such interlocking can be designed to occuras a result of the shape-memory material reverting to its originallyformed shape. Most preferably, the staples 21 are formed of a metalmaterial having legs 23 with flat surfaces of a substantial width. Barbs28 a protrude from facing surfaces, and the legs are designed so thatthe free ends will overlap each other, preferably one above the other sothat the interlocking of the barbs will occur in the plane of the staple21 itself.

[0067]FIG. 5A shows a generally similar staple 29 which might bepreferred when staples are to be first implanted in spaced apartlocations along the valve annulus to create a desired pathway for anannuloplasty ring of open configuration, as described hereinafter. Thestaple 29 has a closed upper ring section 29 a that is appropriatelysized to provide an opening to which an annuloplasty ring might beattached, as described hereinafter. The ring surmounts a pair of curvedlegs 30 which terminate in free ends similar to the barbed free ends 28of the staples 21. To positively prevent the staple from being driventoo deeply into the tissue, a pair of oppositely extending wings 31 areprovided which extend transversely outward preferably perpendicular tothe plane of the staple, as best seen in FIG. 5B. The wings will engagethe surface of the tissue and limit the depth of implantation of thestaple to that desired. Implantation of the staples 29 would begenerally similar to that of the staples 21 described above.

[0068] In the embodiment shown in FIG. 6, a staple 33 of simplerconfiguration is shown. The staple 33 is generally circular in shape, soproportioned to surround the perimeter of a circular cross-sectionannuloplasty ring, and its two spaced-apart free ends 35 are formed withbarbs 37 of the type commonly found at the end of a standard fish hook.Accordingly, these staples 33 can be readily implanted using a surgicalstapler of the type commonly employed; they need not be made of ashape-memory material, as they can be essentially clinched in place bystandard stapling action.

[0069] Two additional staple designs having advantageous features areillustrated in perspective views labeled FIGS. 6A and 6B. Illustrated inFIG. 6A is a staple design 121 which generally resembles staple 21without the two interior bends 25. The staple has two free ends 123,which carry laterally extending barbs 125. The staples 121 would besimilarly placed, so that the annuloplasty ring would reside in thebight of the staple and the free ends would cross. As a result of thedesign, the laterally extending barbs 125 would interengage, thuslocking the staples in place, with the barbs embedded in the hearttissue. The staples could be made of a shape-memory material, or theycould be made of a high grade stainless steel or the like and crimped bya suitable surgical stapling tool. Illustrated in FIG. 6B is a staple133 that generally resembles staple 33. The staple similarly has a pairof spaced apart free ends 135 that are formed with barbs 137. In thisarrangement, the staples 133 are similarly placed so that theannuloplasty ring resides in the bight of the staple, but in thisarrangement, one free end 135 extends in one direction and the otherfree end extends in the essentially opposite direction, both whichdirections are essentially parallel to the axis of this section of theannuloplasty ring. Again, the staples 133 can be formed from ashape-memory material, which will then inherently assume thisorientation, or they may be made of stainless steel or the like andimplanted using a tool which causes this particular deflection of therespective free ends.

[0070] The implantation of a partial annuloplasty ring or band inconjunction with a tricuspid valve is illustrated and described withrespect to FIGS. 7-9. In FIG. 7, a tricuspid valve is shown with twodouble-armed 2.0 pledgetted sutures 41 pulled for retraction. Thetricuspid valve to be reconfigured is gauged, and the size of a partialring 43 desired is determined. The two trigonal sutures 41 are thensutured to the ring 43 at the appropriate sites using suture needles 44integrally attached to the ends thereof, and the ring 43 is lowered intoassociation with the annulus of the valve as shown in FIG. 8. Staples 45as described hereinbefore are radially placed around the annulus in thesequence illustrated in FIG. 11, the sequence of placement beingindicated alphabetically, starting with “A”. More specifically, a staple45 is first placed at the midpoint of the ring, and then two staples 45are placed halfway between the midpoint and each end at the “B”locations. Thereafter, additional staples 45 are placed equidistantbetween pairs of existing staples or between the end of the ring and thenearest staple, in two separate series, i.e. “C” and then “D”, until theillustrated pattern is achieved. By placing the staples 45 in such asequence, maximal anchoring symmetry is obtained which results inmaximal coaptation of the leaflets and competent valve operation. Onceall of the staples 45 are in place, both trigone anchoring sutures 41are ligated, as depicted in FIG. 9. As should be apparent, thissimplified procedure can be completed in a fraction of the time neededfor traditional annuloplasty ring implantation. As a result of theprocedure, the incompetent valve has been effectively reconfigured whilesubtle relative movement is still permitted between the stapled tissueand the annuloplasty ring in a direction axial of the ring, assuringexcellent interengagement of the leaflets.

[0071]FIG. 10 illustrates a mitral valve with a partial annuloplastyring 51 in place, similar to the one described with regard to thetricuspid valve. The pledgetted trigonal sutures 53 will be ligated tothe ends of the generally C-shaped ring 51, as described hereinbefore,following placement of the confining staples 55.

[0072]FIG. 11 shows an alternative type of single wire partialannuloplasty ring 57 in combination with a pattern of staples to whichreference was earlier made to describe the strategic sequentialplacement of staples 45 about an annulus. These staples 45 can beimplanted in locations straddling the wire, or staples 29 might be usedhaving openings in the ring sections such that the wire may be passedtherethrough. Instead of attaching trigonal sutures to a fabric coveringas was previously described with respect to other such rings, the singlewire partial annuloplasty ring 57 is provided with a pair of ears 58 ateach end which are preferably be apertured to facilitate the ligation ofthe trigonal sutures thereto after they are threaded therethrough. The“A” staple is placed first, followed by the two “B” staples, followed bythe four “C” staples, etc.

[0073] Illustrated in FIG. 12 is a fenestrated partial annuloplasty ring61 made of a suitable metal alloy material, e.g. titanium or Nitinol.The generally C-shaped partial ring 61 has a plurality of elongatedwindows 63 running down its spine for its entire length, and a pair ofapertured ears 65 are provided at each end to facilitate attachment oftrigonal sutures 67 thereto. The windows 63 are proportioned so that astaple 69 can be located generally at the midpoint of each window, withone leg of the staple protruding through the window and with the staplepreferably straddling the radially outer edge of the fenestrated, ringas illustrated in FIG. 13. The ring 61 can be flat, but it mayadvantageously be frustoconical, being disposed at an angle of about 10°to about 60° (and preferably between about 10° to about 45°) to thehorizontal (i.e. to the plane which is perpendicular to the axis of thevalve). Either the smaller or the larger diameter edge may be implantedclosest to the valve opening, as there is great variation in the mitralvalves of different patients. With the mitral valve reconstruction shownin FIG. 13, the larger diameter radially outer edge faces the valveopening. Once all of the desired staples 69 are in place, generally onewith respect to each window, the pledgetted trigonal sutures 67 areligated to the attachment ears 65 at the respective ends of the partialring. As can be seen, the elongated windows 63 allow free relative axialmovement between the edge of the fenestrated band and the staples, whichare secured in the heart valve tissue. Again, the staples 69 can be anyof the types depicted in FIGS. 5, 6, 6A and 6B, or they can be of thegeneral surgical variety as it is unnecessary for them to provide adefined portal or bight-shaped to particularly surround thecircumference of a circular cross-section band.

[0074] Illustrated in FIGS. 14-16 is an alternative procedure that maybe used to implant a partial annuloplasty ring, which procedure is shownas being carried out to reconfigure a mitral valve. A pattern of staples71 or other suitable support is first placed in the valve tissue along apath extending from commissure to commissure. More specifically, the twotrigons “T” of the valve are identified, and two double-armed 2.0pledgetted sutures 73 are placed, as in FIG. 2, and pulled forretraction. The mitral ring is identified and if necessary is pulledwith the help of a skin hook. Staples 71 are then placed radially aroundthe annulus from commissure to commissure as illustrated in FIG. 14.Staples of the style of the staples 29 may be used. The two needles ofthe trigonal suture 73 on the left-hand side are then threaded throughholes provided in ears 75 in a connector at each end of a sheathed wiresystem 77 which may include one or two or more wires 79 which will havesufficient flexibility to permit them to be routed through the pathwayprovided by the pattern of staples 71. The wires may be made of a metalalloy or of polymeric material, and they optionally may be of ashape-memory material, such as Nitinol. Their necessary length isdetermined by gauging the valve, and the wire system is constructed toprovide points of attachment at the tail end, e.g. apertured ears 75,through which the two trigonal suture needles can be passed.

[0075] The leading end of the partial band system 77 is elongated toprovide an introduction portion 81 at the end of the sheath whichenvelopes the right-hand end of the two-wire system and has a needle 83threadably connected of its tip end. The needle 83 enables the routingof the wire system 77 between the bights of the staples 71 and thesurface of the tissue in which the staples are implanted. Routing beginsat the left-hand end and proceeds through the entire pathway to theopposite commissure. When the end of the wire system 77 protrudesthrough the last staple, the sheath portion of the system is removed toexpose the pair of apertured ears 75 at the leading end and the pair ofwires 79 that extend end-to-end and constitute the annuloplasty band.Once the trigonal anchoring sutures 73 are ligated to the attachmentears, the installation is complete. If the wires 79, which make up thewire system are of shape-memory material, they will then slowly assumethe desired shape into which the valve is to be reconfigured, and someheating can be supplied, but should not likely be necessary. Once theheart has been closed, and the heart begins to beat on its own, theshape of the valve will steadily improve to an optimum configurationwhere it is fully competent.

[0076] Illustrated in FIGS. 17-22 is a further alternative procedurewhich obviates the need to employ a pair of pladgetted sutures forligation at the trigona. Instead, two individual supports 85 areemployed that can be quickly inserted into and anchored in the tissueprecisely at each trigone and thereafter employed to mount the ends ofan open annuloplasty ring of a type designed to permit some initialadjustment by the surgeon at the time of implantation so as to achievethe precise sizing desired. FIG. 17 shows an support 85 which may beemployed for this purpose; it includes a circular base 87 and has ananchor section including a pointed, barbed shaft 89 which is designed tobecome affixed in the tissue. Once the two trigona have been identifiedwith close precision, one of these supports is anchored at each trigone.The illustrated shaft 89 carries three barbs 91 extending outwardlytherefrom and equiangularly spaced apart, e.g. by about 120°. Thepointed shaft 89 protrudes into the tissue to the desired depth, withthe undersurface of the circular base 87 tightly abutting the surface ofthe tissue, and the design of the barbs 91 is such to resist any upwardwithdrawal of the support. The support 85 includes an upstanding postsection extending upward from the upper surface of the circular base 87which is formed by three initially parallel rods 93 made of ashape-memory alloy, such as Nitinol. In their initial configuration, therods 93 are parallel to the shaft and are surrounded by a restrainingsleeve 95 which is removable as described hereinafter. Once the twosupports 85 have been implanted anchored, the surgeon measures thedistance about the valve annulus from one anchor along the path to theother anchor and selects the size of an open annuloplasty ring.

[0077] Illustrated in FIG. 18 is a fenestrated ring 97 particularlydesigned for implantation with this implantation system. The partialannuloplasty ring 97 resembles that shown in FIG. 12, being made ofsimilar metal, and a plurality of windows 99 run down its spine for itsentire length. However, the ring has a pair of aligned circular holes101 in each end which are sized so as to fit over the sleeve 95 which isrestraining the three upstanding rods. The surgeon chooses one of theholes at each end for the initial installation and starts insertingstaples along the ring using the sequential placement proceduredescribed hereinbefore. After the A and B staples have been installed,the surgeon checks the fit, and if it is felt that the ring is toolarge, the second hole 101 on one end can be placed over the anchor andthe checking repeated. In the unlikely instance that it would still betoo large, a further adjustment can be made by moving the other end ofthe fenestrated ring 97 to the second hole 101. The remaining staplesare inserted, and the restraining sleeves 95 are removed from the groupsof posts at each anchor. Body temperature causes the posts 93 to assumea generally C-shape bending around and over the end sections of thefenestrated ring that form the perimeters of the holes 101 and securelyfastening both ends to the tissue.

[0078] Illustrated in FIG. 19 is a wire ring-type annuloplasty ring 105similar to the wire ring 67 described with respect to FIG. 11. The majordifference is that apertured ears 107 at each end are axially alignedwith the wire itself. Implantation of the ring is preferably carried outgenerally similarly to that just described; however, alternatively,staples could be initially implanted in the tissue to define the desiredpathway and then one end of the wire ring threaded through the path, aspreviously described with regard to FIGS. 14-16. Again, once the twosupports 85 have been anchored at the precise locations of the trigona,the surgeon makes the measurement to determine the length of the ring,and a suitable wire partial ring 105 is selected and installed, asdepicted in FIG. 20. For simplicity purposes, an illustrated wire ring105′ having only a single apertured ear is shown; however, it should beunderstood that the preferred embodiments have two aligned aperturedears 107, as shown in FIG. 19, to permit adjustment. Once the wire ringis suitably aligned, barbed staples 109 are inserted at generally equaldistances apart along the ring using the sequential placement procedurepreviously described. Once a predetermined number of staples 109 are inplace, the surgeon checks the length, and if desired, shortening can beeffected by repositioning one or both ends of the wire ring 105 to placethe second aperture 107 from the end over the upstanding posts of theanchor 85. Thereafter, the restraining sleeve 95 is removed and thetemperature causes the shape-memory alloy posts 93 to curl over theedges of the apertured ears 107, as schematically shown in FIG. 21,locking each ear to the upper surface of the base 87 of the support.

[0079]FIGS. 22 and 23 illustrate an alternative use of barbed staples113 made of a shape-memory material such as Nitinol alloy. The staples113, when implanted, have the U-shape depicted in FIG. 22 in theright-hand view. The shape-memory staples, upon warming to a temperatureof the heart tissue, begin to slowly close as depicted in the middleview until they reach the closed configuration where the barbsinterlock, as shown in the left-hand view and described hereinbefore. Asdepicted in FIG. 23, these shape-memory staples 113 thus securely fix apathway for a wire ring, and once it is decided that either noadjustment to the length is necessary or once such adjustment is made byselecting a different one of the pair of apertured ears, the restrainingsleeve 95 is removed so the three parallel posts 93 shown in FIG. 23 canthen automatically curl radially outward to wrap around the edges of therespective apertured ear and assume the final orientation depicted inFIG. 21.

[0080] Instead of using an integral annuloplasty ring, it has been foundthat an alternative method can very effectively employ a series ofsupports which comprise linkers made of shape-memory material, such asNitinol alloy, which will interconnect spaced-apart supports locatedalong a desired pathway along a portion of the annulus of a patient'smitral or tricuspid valve so as to form a chain. The effective length ofeach linker decreases when they reach body temperature and causes thevalve to assume the desired curvature at which the valve leaflets willperform effectively.

[0081] By effective length is meant the distance between the oppositeends of the linkers. Illustrated in FIG. 24 is a support 121 which has adepending anchor section 123 and an upstanding post section 125 whichincludes a circular portal or loop. A linker in the form of an arm 127extends from an edge of the portal and is made of shape-memory material.The linker arm has the form of a stiff wire having engaging means at itsend in the form of a hook 129. In the illustrated embodiment, thesupport 121 is formed from a single piece of wire alloy with the anchorsections 123 being formed as a plurality of barbs that radiate from acentral core region. Alternatively, a shaft as previously described withrespect to the supports 85 with a series of radial barbs could be usedthat is affixed to the shape-memory linker, and the portal could be apart of either the shaft or the arm.

[0082] The surgeon who is reconfiguring the heart valve places a support121′ that is devoid of a linker arm at one trigone, as illustrated inFIG. 26. A series of supports 121 are then implanted along the desiredpath that will provide the desired curvature of the valve so theleaflets will regain their effectiveness in blocking flow through thevalve in the reverse direction. In each instance, the hook 129 at theend of the arm 127 of a support 121 is interengaged with the portal inthe post section 125 of the last implanted support as it then has itsanchor section 123 forced into the annulus tissue to implant it alongthe path to create the arrangement for a mitral valve as illustrated inFIG. 26. This results in a chain of interengaging linkers from support121 to support 121 along the entire arcuate path selected to reconfigurethe valve.

[0083] As the shape-memory alloy material slowly reaches bodytemperature, the material returns to the original shape in which it wasformed, which is shown in FIG. 25 as shape “b”. More specifically, thestraight arm 127 changes from its linear form (shape “a” in FIG. 24)when implanted to now have a series of bends or undulations 131, asdepicted in FIG. 25; this shortens the effective length of each linkerarm and causes the implanted supports 121 to be drawn closer to oneanother, thereby shortening the length of the arcuate chain and reducingthis portion of the annular circumference to the desired dimensionscalculated by the surgeon. At the same time, the hooks 129, that wereinitially interengaged through the portals, close into circular loopsthus securing the interengagement between the end of the linker arm andthe next adjacent support, as also shown in FIGS. 25 and 27. Althoughthe path along which these supports are located preferably extends fromabout one commissure to the opposite commissure, there may be instanceswhere the use of supports extending a substantial distance along suchpath may be adequate. Usually such a substantial distance willconstitute at least about 50 or 60% of the total distance, andpreferably at least about 80%.

[0084] Shown in FIG. 28 is an alternative embodiment of a support 135which includes a similar anchor section 137 (but which could also be abarbed shaft as shown in FIG. 17) wherein the upstanding sectionincludes a base 139 in the form a cross or X-shape to which are affixeda pair of parallel arms 141 which are made of stiff, shape-memory alloymaterial of wire form. The arms are formed with a pair of hook sections143, the ends of which are joined by a crossbar 145, forming a firstinterconnector. The opposite ends of the two arms 141 are also formed ashook sections 147 the termini of which are affixed to a crossbar 149(which may be integral therewith) to form a second interconnector. Thecrossbars 145 and 149 differ slightly in size so that the respectivehook sections are spaced apart slightly differently so that the smallerinterconnector at one end of a support 135 can be fit between the hooksections of the larger interconnector and thus juxtaposed with theinterconnector at the opposite end of the next adjacent support in thepath so that they interengage with the smaller interconnector loopingaround the crossbar of the larger.

[0085] When the implanted supports 135 reach body temperature, theshape-memory alloy causes the hook sections 143 and 147 to change shapeto form closed loops. At about the same time or preferably slightlythereafter, the arms 141 effectively shorten by the creation ofundulating bends 151, as seen in FIG. 29. As a result, the longer of thetwo crossbars 145, 149 is now encircled by the smaller interconnector atthe other end of the next adjacent support 135, locking the two ininterengagement. It can thus be seen that for a chain of these supports135 wherein the pair of arms 141 on each support has decreased ineffective length results in a reconfiguration of the curvature of thevalve in the same manner as that illustrated in FIG. 27.

[0086] Although the arrangement of the support that is illustrated inFIGS. 28 and 29 locates the base 139 near one end of the linker formedby the pair of arms 141, it should be understood that, if desired, asupport 152 may have a base 153, from which the anchor section 154depends, located generally centrally of the ends of the pair of arms 155and hook sections 157 which both bend upward, as shown in FIGS. 30 and31, but include crossbars 145, 149 of different lengths. In thisinstance, the arms 155, in both regions between the base 153 and thehook sections 157, would form undulations 159 flanking the central basesection. FIG. 31 shows the form which such an alternative support 152would have at the time at which it would be implanted, and FIG. 32 showsa section of a chain of such interconnected supports 152 after the arms155 have formed a series of undulations 159. Although the undulations159 are shown as lying in a vertical plane, the support mayalternatively be formed so that they lie essentially in a horizontalplane parallel to the surface of the valve tissue.

[0087]FIGS. 14A-14C illustrate an alternative embodiment of a method forreconfiguring an atrioventricular heart valve to that shown in FIGS. 14,15 and 16. Instead employing a flexible wire of shape-memory alloymaterial that is threaded through the staples, a similar series ofstaples 71 are implanted along the desired path as before, and inaddition, two additional staples are implanted near the commissureswhere the sutures were previously ligated. Adjacent pairs of staples 71are then serially interconnected by linkers 161 of stiff wire form whichembody an arm 163 and a pair of hooked ends 165. Each linker 161 ishooked at one end about one of the implanted staples 71 and then theopposite end of the linker is hooked about the next adjacent staplealong the path until the entire chain of staples from commissure tocommissure has been put in place. The staples 71 are of shape-memoryalloy material, such as described in FIG. 22 for example; theypreferably will have already achieved a secure or interlockedconfiguration before the linkers are attached. As the temperature of thelinkers arises to the body temperature, the hook ends 165 of each of thelinkers deform into essentially closed loops, and the arms 163 of thesupports return to their original configuration to present a series ofundulations 167 which effectively shorten the length the linkers,pulling the adjacent pairs of staples toward one another andreconfiguring the valve to assume the desired curvature where theleaflets will effectively close to prevent blood flow in the oppositedirection during the pumping cycle of the heart.

[0088] These staples and various of the other supports illustratedherein may be delivered by a special gun having a size such that it canintroduced through a cardiac catheter which enters from a patient'sgroin, and following the implantation of the staples in this manner, thesimple linkers 161 can be similarly placed by the surgeon non-invasivelythrough such a cardiac catheter. The placement of supports similar tothe supports 121 non-invasively is described and shown in FIGS. 40-43hereinafter.

[0089]FIG. 33 illustrates the elements of another system that can beused to reconfigure an atrioventricular heart valve, alternative to thatillustrated in FIGS. 28 and 29 and that illustrated in FIGS. 30-32. Thesystem employs a central support member 171 and separate linkers 173.The central support 171 includes an anchor section 175 and a base 177from which the anchor section depends. The base is formed with a pair ofslots 179 that define crossbars 181 adjacent opposite edges of the base.

[0090] The linkers are made in wire form and include a pair of generallyparallel arms 183 which end in hook sections 185. At each of the twoends of the linkers 173, the parallel arms 183 are interconnected by apair of crossbars 187 a and 187 b. The crossbars stabilize the ends ofthe linkers 183.

[0091] During the implantation, the surgeon first implants a series ofspaced apart support members 171 along the desired path as explainedhereinbefore. Each of the anchor sections 175 is forced into the annulustissue, and it is retained in place by barbs 189 formed as a partthereof. As the support members 171 gradually warm to body temperature,the anchor section 175 of shape-memory material begins to slowly changeshape. It is formed as a pair of split legs 191, and as seen in FIG. 34,the ends of these legs slowly spread radially in opposite directionsthus further securing the barbed elements within the annulus tissue. Thelinkers 173 are then installed between adjacent central supports 171 bysequentially hooking the hook ends 185 of the arms through the slots 179so they partially wrap around the crossbars 181 of the base 171; thisconfiguration is shown in FIG. 34. FIG. 35 shows the next step where,upon warming, the hook ends 185 deform into essentially closed loopswhich effectively encircle each of the crossbars 181, completelysecuring the interengagements. At about the same time or preferablyshortly thereafter, the arms 183 have warmed sufficiently to return totheir original shapes in the form of a series of undulations or bends193, effectively shortening the length of the linkers and pulling thecentral supports toward one another to create the desired curvature ofthe heart valve. This final arrangement is schematically shown in FIG.36 without illustrating the associated heart valve, as was shown withvarious of the earlier systems.

[0092] Illustrated in FIG. 37 is an alternative embodiment of a centralsupport 197 that might be employed instead of the central support 171illustrated in FIG. 33. This support may employ a similar base section;it employs an anchor section 199 which is split into four barbed legs201 which, upon warming, bend radially outward at their free ends,generally at 90° angles to one another, to take the implanted form shownin FIG. 37.

[0093]FIG. 38 depicts yet another alternative embodiment of a centralsupport 203 which maybe formed with either of the previously describedanchor sections but which employs a base section 205 of wire formgenerally similar to that shown in FIGS. 28 and 29. The base includes apair of hooked interconnectors 207 which include crossbars 209 thatfunction the same manner as the crossbars 181 described just above.

[0094]FIG. 39 depicts an alternative embodiment of a linker 211 showngenerally in the form it would take following implantation. It has apair of hooked ends 213 generally similar to the hooked ends 185 whichinclude crossbars; however, instead of having a pair of parallel arms, asingle arm 215 is employed which, upon warming to body temperature,forms a series of undulations 217 which effectively shorten its length.

[0095] Various of the previously described systems may be employed innon-invasive narrowing of the mitral valve, particularly in a patientsuffering congestive heart failure (CHF). The system would permitnon-invasive means being employed to actually repair the valve byentering the artery in the groin region using delivery-catheter basedtechnology. Shown schematically in FIG. 40 is a catheter 221 of theguidable variety well known in this art which can be employed to delivera plurality of supports 223, such as supports as generally shown in FIG.24 that are preferably, but not necessarily, linked together in a chainof the desired length. The catheter 221 may be made in accordance withany of the commercially available designs for guidance and delivery,such as those found in U.S. Pat. Nos. 6,723,082; 6,663,666; 6,482,221;and 6,572,643. Generally these catheters 221 will have as many as foursteering wires 225 arranged for example at annular locations at 90° toone another, as shown schematically in a cross-sectional view in FIG.41.

[0096] As well known in this art, these catheters 221 would carry theelectronic and space sensing elements to facilitate the manipulation andoperation of the delivery catheter. For example, the end of the catheterwould likely be provided with the electro-magnetic sensors 227 whichwould allow the operator to precisely identify the location of the tipof the catheter within the body of the patient spatially on X, Y and Zaxes, as determined from a platform on which the patient would be lying.In addition to knowing the spatial location of the catheter tip,ultrasonic sensors/transducers would be likely provided that would showthe relative position of the tip with reference to the contour of theheart tissue and with an electrode using electrical mapping of themitral annular region (here the interior wall of the left ventricle) sothat, in this instance, the cardiologist would be able to preciselyposition the tip of the catheter along the region of the circumferenceof the mitral valve that is to be shortened through this surgicalprocedure.

[0097] The catheter 221 would be inserted from the patient's groin,retrograde into the aorta and then through the aortic valve 231 into theleft ventricle as depicted schematically in FIG. 42. Suitable guidancesystems of this type are available and are shown for example in U.S.Pat. No. 6,322,548 where a catheter is similarly delivered; once inplace within the left ventricle of the heart, it is used to deploy asharp or needle through an injection is made. Such an operation isdepicted in FIGS. 9 through 11 of this patent, where wire loops made ofNitinol are used to serve as penetration limiters and wherein, once theoperator has determined that the device is in the correct position, thedistal tip of the needle is extended into the heart tissue.

[0098] In the system illustrated herein, the first support 223 would beprojected through the open end of the delivery catheter with its pointedanchor portion 223 positioned against the heart tissue at the locationwhere it is desired that shortening of the valve circumference shouldbegin. The distal end of the catheter carries an inserter 235 which isdesigned to grasp the support 223 in the region above the anchor andforcefully insert it into the heart tissue. After the initial support223 has been implanted, the catheter 221 is manipulated so as toposition the next support 223 at its desired location, with an arm 237of the support interconnecting the two. Although totally separatesupports could be employed that would be linked together using any ofthe systems previously described herein, the operation may be simplifiedif the supports are already interlinked as a chain when they are loadedinto the delivery catheter 221. With the second support 223 in position,it is then also forcefully inserted into the tissue by activating theinserter 235. The operation is repeated until the chain of the desiredlength selected by the surgeon has been placed in the desired location.

[0099] Once the installation has been complete, the delivery catheter221 is withdrawn, and the chain of interlinked supports 223 would appearas shown in FIG. 43. If the shape-memory material is of the Nitinolalloy type, the arms 127 automatically shorten upon warming to bodytemperature, and the reduction in the circumference of the mitral valveoccurs. If some other type of shape-memory material were to be employed,the application of energy e.g., selected electrical current, UV,ultrasound or the like, might be employed to cause the material toregain its initial shape where the arms will have shortened in effectivelength via the creation of a plurality of undulations, as describedhereinbefore.

[0100] Whereas, heretofore when it was deemed feasible to avoidreplacement of a valve that had become incompetent by implantation of anannuloplasty ring, this operation has been greatly facilitated via theuse of the previously described stapling procedures. By reducing thetime of such phase of an operation by 50% or more, side effects of beingan artificial life support are greatly lessened, and full recovery issignificantly hastened.

[0101] Although the invention has been described with regard to certainpreferred embodiments, it should be understood that various changes andmodifications that would be obvious to one having the ordinary skill inthis art may be made without departing from the scope of the inventionwhich is defined in the claims appended hereto. For example, althoughonly certain specific staple shapes have been illustrated, it should beunderstood that a wide variety of staples, made optionally ofshape-material, may be employed as the surgical stapling has become awell developed art. There are commercially available a number of customdesignable staplers which can be employed to anchor annuloplasty ringswhile working at a distance of 25-35 centimeters from the annulus of amitral valve. In the supports that use linkers in the form of pairs ofgenerally parallel arms, the hook sections at each end at the respectiveends of the arms may be arranged in varying orientations. Although itmay be preferred that both hook sections curve upward from the arms withrespect to the heart valve tissue against which the arms will begenerally juxtaposed as depicted in FIGS. 30-32, it should be understoodthat, depending upon the size and length of the support and theorientation of the pair of arms, one or both of the hook sections couldbe formed to curve downward as shown in FIG. 28 to perhaps facilitateinterengagement. It should likewise be understood that althoughdifferent types of barbed ends of staples and anchors have beendescribed with respect to different of the embodiments, essentially anyof the individual arrangements can be substituted for those specificallydescribed with regard to a specific embodiment when felt desired for aparticular application. For example, any of the staples or the anchorscould be constructed so as to be formed of a shape-memory alloy materialthat would deform after implantation into 2, 3, 4 or more spreadinglegs. The disclosures of all U.S. patents mentioned hereinbefore areexpressly incorporated herein by reference.

[0102] Particular features of the invention are emphasized in the claimsthat follow.

1. A method of reconfiguring an atrioventricular heart valve, whichmethod comprises providing an annuloplasty ring sized and shaped to havea desired configuration, and implanting said ring at the mitral ortricuspid valve of a patient by implanting a plurality of staples in thepatient's heart tissue so as to spatially position said annuloplastyring in a reconfiguration association therewith, while providing thetissue, in which said staples are implanted, the ability to shiftaxially with respect to said ring.
 2. The method of claim 1 wherein saidring is secured directly to the heart tissue by sutures located at thetrigons of the valve.
 3. The method of claim 2 wherein said annuloplastyring is a partial ring and said trigonal sutures are respectivelyligated to the opposite ends of said partial ring.
 4. The method ofclaim 3 wherein said staples are implanted in association with saidpartial ring in accordance with a pattern wherein the first staple isimplanted near the midpoint of said partial ring and a pair of staplesare next implanted at about the halfway points between said midpoint andthe respective ends.
 5. The method of claim 4 wherein the remainder ofthe staples are respectively positioned so as to be approximatelyequidistant between two already implanted staples or between an alreadyimplanted staple and said end of said partial ring.
 6. The method ofclaim 1 wherein each said staple has a pair of legs which respectivelyhave inwardly protruding opposed arms that form a portal extending abovethe tissue surface into which the staples are implanted, said portalbeing sized to allow said ring to move axially therewithin.
 7. Themethod of claim 6 wherein said staples are formed of a shape-memorymaterial and said legs assume a secure angular orientation within thetissue following implantation.
 8. The method of claim 1 wherein saidstaples have pairs of legs which have free ends that form aninterlocking orientation following implantation as a result being formedof shape-memory material.
 9. The method of claim 1 wherein saidannuloplasty ring is fenestrated, being formed to have elongatedwindows, and wherein said staples have pairs of legs and are implantedwith one leg of each extending through one of said windows.
 10. Themethod of claim 1 wherein ends of said ring are secured directly to theheart tissue by anchors implanted into the heart tissue.
 11. A method ofreconfiguring an atrioventricular heart valve, which method comprisesimplanting supports along a portion of the annulus of the mitral ortricuspid valve of a patient along a path extending from about onecommissure toward the opposite commissure to provide a path therealong,said supports being implanted in spaced apart locations and havingupstanding portions which extend above the tissue surface, andinterconnecting said upstanding portions using shape-memory materialwhich decreases in effective length subsequent to implantation, saidchange in length of said shape-memory material causing the valve toassume the desired curvature following implantation.
 12. The method ofclaim 11 wherein each said upstanding portion contains an open portalthrough which a flexible wire of shape-memory material is routed so asto extend along said path which extends from commissure to commissure,and wherein respective ends of said wire are secured to sutures or otheranchors installed in the heart tissue at each trigone.
 13. The method ofclaim 11 wherein said upstanding portions of said supports areinterconnected to one another along said path by linkers which areformed of shape-memory material, which interengage with an upstandingportion of an adjacent support along said path to create a generallyarcuate chain along said path.
 14. The method of claim 13 wherein saidlinkers each include an arm which has a hook at an end thereof to engagethe next adjacent upstanding portion, said arms being formed of saidshape-memory material.
 15. The method of claim 14 wherein each saidlinker includes a pair of said arms which are joined at said hook endsto form a first interconnector, which first interconnector is adapted tointerengage with a second interconnector which forms a part of saidupstanding portion of said adjacent support.
 16. The method of claim 15wherein said supports each include two pairs of arms that extend inopposite directions, said respective hook ends thereof forming saidfirst and second interconnectors.
 17. The method of claim 16 whereinsaid first interconnector at the ends of one said pair of arms of eachsaid post is smaller than said second interconnector so as to fitbetween the respective arms supporting said adjacent secondinterconnector during the implanting step.
 18. The method of claim 11wherein separate linkers, which are formed of shape-memory material, areused to interengage with said upstanding portions to create a generallyarcuate chain along said path which may extend from one commissure tothe opposite commissure.
 19. The method of claim 11 wherein saidsupports and linkers, which are formed of shape-memory material, areused and are inserted non-invasively through a delivery catheter tocreate a generally arcuate chain along said path.
 20. A system forreconfiguring an atrioventricular heart valve, which system comprises apartial or complete annuloplasty ring having a size and shapeproportioned to reconfigure a heart valve of a patient that has becomein some way incompetent, a pair of trigonal sutures or implantableanchors, and a plurality of supports having pairs of legs that are sizedand shaped for association with said ring at spaced locations along thelength thereof in a manner that permits relative axial movement betweensaid supports and said ring, whereby a patient's heart valve can bereconfigured in a manner that does not deter subtle shifting of thenative valve components.
 21. The system according to claim 20 whereinsaid supports are staples each having a pair of inwardly protrudingopposed arms that form a portal extending above the surface of thetissue into which the staples are implanted.
 22. The system according toclaim 21 wherein said staples are made of a shape-memory material andwherein said legs have free ends which change shape to assume a secureangular orientation to the major length thereof following implantationin the tissue of the patient.
 23. The system according to claim 22wherein said legs have free ends that form an interlocking orientationfollowing implantation.
 24. The system according to claim 20 whereinsaid annuloplasty ring is a partial fenestrated ring having a pluralityof spaced-apart elongated windows.
 25. The system according to claim 24wherein said pair of anchors are adapted for implantation near thecommissures of the heart valve which have shape-memory posts and whereinsaid partial ring has a pair of aligned holes at one end which areproportioned to fit over said upstanding posts and permit adjustment ofthe effective length of the partially installed ring prior to said postschanging shape to secure said ring ends thereon.
 26. A system forreconfiguring an atrioventricular heart valve of a patient that hasbecome in some way incompetent by the creation of a generally annularchain that decreases in length following implantation in a patient,which system comprises: a plurality of supports having anchor sectionsthat are shaped for implantation into annulus tissue at spaced locationsalong a path that extends generally from commissure to commissure, and aplurality of linkers having arms made of shape-memory material which areadapted to interconnect adjacent of said supports along said path tocreate such a chain extending generally for a substantial distance alonga path from one commissure to the opposite commissure, whereby apatient's heart valve is reconfigured when said linker arms decrease ineffective length, which reconfiguration does not deter subtle shiftingof the native valve components.
 27. The system according to claim 26wherein said anchor sections each have a plurality of shape-memorymaterial legs which change in shape, with their free ends movingradially outward to assure a secure orientation.
 28. The systemaccording to claim 26 wherein said linkers are made completely ofshape-memory material and have a hook portion at each end of said arm.29. The system according to claim 26 wherein each said linker is affixedto one support at one end and has engaging means at the opposite endthereof to interconnect to the next adjacent said support.